Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy

NCT ID: NCT03648008

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-05
• Study Completion Date: 2018-09-01

Brief Summary

Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Multimodal analgesia combines several agents and/or techniques to function on diverse nociceptive mechanisms to enhance pain relief and lessen side effect. Hydromorphone is a hydrogenated ketone of morphine and approximately 5-10 times more potent. There lacks about efficacy and efficiency of hydromorphone in electrical pump for patient controlled intravenous analgesic (PCIA).

Conditions

Pain, Postoperative; Thoracic Surgery, Video-Assisted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group M

Drug: Morphine Background: No Bolus infusion: 0.015 mg\*kg-1

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

0.015 mg\*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.

Group NBH

Drug: Hydromorphone Background: No Bolus infusion: 0.002 mg\*kg-1

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

0.002 mg\*kg-1 bolus with 0.002 mg\*kg-1 background infusion for group BH 0.002 mg\*kg-1 bolus without background infusion for group NBH Drug is administered through PCIA pump.

Group BH

Drug: Hydromorphone Background: 0.002 mg\*kg-1\*h-1 Bolus infusion: 0.002 mg\*kg-1

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

0.002 mg\*kg-1 bolus with 0.002 mg\*kg-1 background infusion for group BH 0.002 mg\*kg-1 bolus without background infusion for group NBH Drug is administered through PCIA pump.

Interventions

Hydromorphone

0.002 mg\*kg-1 bolus with 0.002 mg\*kg-1 background infusion for group BH 0.002 mg\*kg-1 bolus without background infusion for group NBH Drug is administered through PCIA pump.

Intervention Type: DRUG

Morphine

0.015 mg\*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 70≥ Age ≥18
• Selective operation lung section with video-assisted thoracic surgery (VATS)
• III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I
• Patients informed and agreed to join the study

Exclusion Criteria

• Abnormal function of liver and kidney
• Allergic- dependence history of alcohol, opioids and Local anesthetics
• No noncompliance
• Mental disease history，language communication disorder，cicatricial diathesis
• Underweight or overweight（BMI<18 or >30)
• Patients not suitable for clinical subjects for other reasons
• Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24 hours before the operation.
• History of previous abnormal anaesthesia
• Women during pregnancy or lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Yan, Doctor

Role: STUDY_CHAIR

Zhejiang University

Locations

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2018-014

Identifier Type: -

Identifier Source: org_study_id